Hanmi Flu Suspended Powder 6mg/mL (Oseltamivir)

Adult dose

Start treatment on the first or second day after the onset of influenza symptoms. This medicine may be administered regardless of food intake; in some patients, taking it with food may improve tolerability. Treatment of influenza A and influenza B virus infections: Adults and adolescents aged 13 years and older should take oseltamivir 75 mg orally twice daily for 5 days. Adults and adolescents aged 13 years and older who have difficulty swallowing capsules should take this medicine. Patients with renal impairment: No dosage adjustment is necessary for patients with creatinine clearance of 60 mL/min or greater. For patients with creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg twice daily for 5 days is recommended. For patients with creatinine clearance of 10 ～ 30 mL/min, a reduced dose of 30 mg once daily for 5 days is recommended. Patients receiving regular hemodialysis should receive a 30 mg dose of this medicine after each dialysis session to maintain blood concentrations within the therapeutic range; treatment should not exceed 5 days. If influenza symptoms occur during the 48 hours between dialysis sessions, the dose may also be administered before the start of dialysis. For peritoneal dialysis, a single 30 mg dose of this medicine after dialysis is recommended. The pharmacokinetics of oseltamivir have not been studied in patients with end-stage renal disease who are not receiving dialysis (e.g., creatinine clearance below 10 mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is necessary for treatment in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9). Prevention of influenza A and influenza B virus infections: Adults and adolescents aged 13 years and older who are in close contact with an infected person should take oseltamivir 75 mg orally once daily for 10 days. Start administration within 2 days of contact with the infected person. The recommended dose for prevention during an influenza epidemic is 75 mg once daily. The safety and efficacy of this medicine have been demonstrated for up to 6 weeks. The preventive effect continues while this medicine is being taken. Patients with renal impairment: No dosage adjustment is necessary for patients with creatinine clearance of 60 mL/min or greater. For patients with creatinine clearance of 30 ～ 60 mL/min, a reduced dose of 30 mg once daily is recommended. For patients with creatinine clearance of 10 ～ 30 mL/min, a reduced dose of 30 mg every other day is recommended. Patients receiving regular hemodialysis should receive a 30 mg dose of this medicine after every 2 dialysis sessions to maintain blood concentrations within the therapeutic range. The initial dose may also be administered before the start of dialysis. For peritoneal dialysis, 30 mg of this medicine once weekly after dialysis is recommended. The pharmacokinetics of oseltamivir have not been studied in patients with end-stage renal disease who are not receiving dialysis (e.g., creatinine clearance below 10mL/min); therefore, no recommended dose is available for these patients. Patients with hepatic impairment: No dosage adjustment is necessary for prevention in adult patients with mild to moderate hepatic impairment (Child-Pugh score ≤ 9).

Child dose

Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75 mg capsules twice daily or 30 mg capsules and 45 mg capsules twice daily instead of the recommended dose of this medicine. Treatment, body weight ≤ 15 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Treatment, body weight 15 kg<, ≤ 23 kg: 45 mg twice daily; suspension (6mg/mL) 7.5 mL twice daily Treatment, body weight 23 kg<, ≤ 40 kg: 60 mg twice daily; suspension (6mg/mL) 10.0 mL twice daily Treatment, body weight > 40 kg: 75 mg twice daily; suspension (6mg/mL) 12.5 mL twice daily Children aged 2 weeks to under 1 year: The recommended dose for pediatric patients aged 2 weeks to 12 months is 3mg/kg of this medicine orally twice daily for 5 days. This does not apply to infants with a postconceptional age of less than 36 weeks. Treatment, body weight 3 kg: 9 mg twice daily; suspension (6mg/mL) 1.5 mL twice daily Treatment, body weight 4 kg: 12 mg twice daily; suspension (6mg/mL) 2.0 mL twice daily Treatment, body weight 5 kg: 15 mg twice daily; suspension (6mg/mL) 2.5 mL twice daily Treatment, body weight 6 kg: 18 mg twice daily; suspension (6mg/mL) 3.0 mL twice daily Treatment, body weight 7 kg: 21 mg twice daily; suspension (6mg/mL) 3.5 mL twice daily Treatment, body weight 8 kg: 24 mg twice daily; suspension (6mg/mL) 4.0 mL twice daily Treatment, body weight 9 kg: 27 mg twice daily; suspension (6mg/mL) 4.5 mL twice daily Treatment, body weight 10 kg: 30 mg twice daily; suspension (6mg/mL) 5.0 mL twice daily Children aged 1 to 12 years: Pediatric patients weighing more than 40 kg who are able to swallow capsules may take 75 mg capsules once daily or 30 mg capsules and 45 mg capsules once daily for 10 days instead of the recommended dose of this medicine. Prevention, body weight ≤ 15 kg: 30 mg once daily; suspension (6 mg/mL), 5.0 mL once daily Prevention, body weight 15 kg<, ≤ 23 kg: 45 mg once daily; suspension (6 mg/mL), 7.5 mL once daily Prevention, body weight 23 kg<, ≤ 40 kg: 60 mg once daily; suspension (6 mg/mL), 10.0 mL once daily Prevention, body weight > 40 kg: 75 mg once daily; suspension (6 mg/mL), 12.5 mL once daily The safety and efficacy of this medicine for the prevention of influenza A and B virus infections in children under 1 year of age have not been evaluated.

This drug is used for the treatment and prevention of influenza virus infections; however, it cannot replace influenza vaccination. This drug is only effective against influenza A and B viruses, and its safety and efficacy have not been established against other infections. Particularly in children and adolescents, neuropsychiatric side effects, such as seizures or abnormal behavior, have been reported rarely, and caregivers should monitor for any unusual behaviors immediately. This medication should not be used by individuals with hypersensitivity to the drug or its components. Patients with impaired kidney function may need dose adjustments, and it is not recommended for patients with end-stage renal failure. High-risk patients, such as those with asthma or chronic bronchitis, should use this medication with caution. Side effects such as nausea, vomiting, headache may occur, though most are temporary. Rarely, skin rashes, liver function abnormalities, acute renal failure, or neuropsychiatric symptoms may occur; patients should seek immediate medical attention if these symptoms appear. Pregnant or nursing women should only use this drug if the therapeutic benefit outweighs the risks. Children under 1 year of age should not use this medication, as safety and efficacy have not been established. Elderly patients should be monitored carefully when administered, as they may have decreased physical function. This drug has a low potential for drug interactions; however, caution is necessary when used with medications affecting renal excretion. Adhere to the prescribed dosage and timing; if a dose is missed, it can be taken as soon as possible but should be skipped if it is within 2 hours of the next dose. This medication is most effective when taken at the onset of influenza symptoms. Store in a sealed container to avoid exposure to air or moisture. A storage temperature of 1 to 30 degrees Celsius (room temperature) is recommended to maintain the drug's efficacy and safety.

Convulsions, delirium, abnormal behavior, nausea, vomiting, headache, pain, unstable angina, anemia, pseudomembranous colitis, pneumonia, peritonsillar abscess, humeral fracture, hallucinations, convulsions, dermatitis, rash, urticaria, eczema, shock, anaphylactic reactions, urticaria, facial and laryngeal swelling, respiratory distress, hypotension, hepatitis, abnormal liver function, jaundice, skin and mucous membrane hypersensitivity syndrome, toxic epidermal necrolysis, acute renal failure, leukopenia, thrombocytopenia, consciousness disturbance, abnormal behavior, delirium, hallucinations, delusions, convulsions, hemorrhagic colitis, erythema, urticaria, erythema, itching, subcutaneous hemorrhage, cheilitis, stomatitis, hematochezia, melena, hematemesis, peptic ulcer, abdominal distension, abnormal stool, oral discomfort, loss of appetite, excitement, tremors, paresthesia, lethargy, drowsiness, ventricular tachycardia, premature ventricular contractions, electrocardiogram abnormalities, palpitations, dysmenorrhea, dizziness, fatigue, fever, influenza-like symptoms, limb pain, pneumonia, sinusitis, bronchitis, otitis media, cough, congestion, asthma, epistaxis, diarrhea, abdominal pain, conjunctivitis, ear pain, dermatitis, sleep disturbances, lymphadenitis, tympanic membrane abnormalities, hematochezia, melena, hematemesis, peptic ulcer, hematuria, proteinuria, eosinophilia, visual disturbances, fever, hypothermia, edema, increased blood glucose, abdominal pain, chest pain, arrhythmia, seizures, confusion, gastrointestinal bleeding, hemorrhagic colitis, worsening of diabetes, eosinophilia, leukopenia, pancreatitis, angioedema, laryngeal edema, tongue edema, bronchial spasm, facial edema, hematuria, nightmares, dizziness, dermatitis

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. Maintain a storage temperature between 1 to 30 degrees Celsius (room temperature) for optimal effectiveness and safety.

Appearance

A suspension that consists of a white to light yellow powder in a brown glass bottle, accompanied by a colorless transparent plastic measuring cup for preparation and use.

Package unit

6.3g (50mL) / bottle